Randomized phase III trial of gemcitabine plus nab-paclitaxel versus gemcitabine plus S-1 as neoadjuvant chemotherapy for resectable pancreatic cancer in geriatric patients: JCOG2101C (PRESTIGE study)

Neoadjuvant gemcitabine plus S-1 (GS) followed by surgery and adjuvant S-1 is the standard of care for resectable pancreatic cancer. Since ~73% of newly diagnosed pancreatic cancer patients are aged ≥70, effective treatments are strongly needed in this geriatric population. In unresectable pancreatic cancer, gemcitabine plus nab-paclitaxel (GnP) is widely used, even among geriatric patients. To evaluate the survival advantage of neoadjuvant GnP over GS for geriatric patients with resectable pancreatic cancer, an open-label randomized phase III trial (JCOG2101C) has been initiated since October 2022. A total of 400 patients will be enrolled from 28 institutions within 3 years. The primary endpoint is overall survival. This trial was registered at the Japan Registry of Clinical Trials as jRCTs031220351 https://jrct.mhlw.go.jp/latest-detail/jRCTs031220351.